Intra Incisional Infiltration of Bupivacaine Versus Meloxicam on Post Cesarean Section Pain Relief

Sponsor
Menoufia University (Other)
Overall Status
Completed
CT.gov ID
NCT04538391
Collaborator
(none)
105
1
3
14.2
7.4

Study Details

Study Description

Brief Summary

Investigation: compare the effect of local infiltration of incision site with bupivacaine and local infiltration with meloxicam in women undergoing cesarean sections on postoperative pain relief and analgesic requirement.

Condition: post cesarean sections analgesia intervention: infiltration of incision bupivacaine versus meloxicam Phase: Not applicable

Condition or Disease Intervention/Treatment Phase
  • Drug: local ifiltration Bupivacaine, Meloxican and placebo
N/A

Detailed Description

study type: randomized clinical trial actual enrollment: 119 allocation: Random intervention model: three groups assignment masking: open lebal primary purpose: pain relief after Cesarean section actual study start: March 3, 2019 Primary Completion: March 5, 2020 actual study completion date: May 9, 2020

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Group A (bupivacaine group): included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with 20 ml of 0.25% bupivacaine hydrochloride. (Marcaine, 25% vial, Astra Zeneca) diluted in 20 ml of 0.9% saline. Group B (meloxicam group): included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with meloxicam 15mg (Anticox 2 ampoule 15mg/3ml, ADWIA Pharmaceuticals). diluted in 20 ml of 0.9% saline. Group C (placebo group): included 35 patients in which skin and subcutaneous tissue was infiltrated with 20 ml 0.9% saline.Group A (bupivacaine group): included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with 20 ml of 0.25% bupivacaine hydrochloride. (Marcaine, 25% vial, Astra Zeneca) diluted in 20 ml of 0.9% saline. Group B (meloxicam group): included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with meloxicam 15mg (Anticox 2 ampoule 15mg/3ml, ADWIA Pharmaceuticals). diluted in 20 ml of 0.9% saline. Group C (placebo group): included 35 patients in which skin and subcutaneous tissue was infiltrated with 20 ml 0.9% saline.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Each woman received a disposable syringe containing a medication corresponding to her order of participation in the trial. Packing. Sealing and numbering were performed by health care provider who did not actively share in the process of the study.
Primary Purpose:
Prevention
Official Title:
Bupivacaine Versus Meloxicam Infiltration on Post Cesarean Section Pain Relief
Actual Study Start Date :
Mar 3, 2019
Actual Primary Completion Date :
Mar 5, 2020
Actual Study Completion Date :
May 9, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: bupivacaine group

included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with 20 ml of 0.25% bupivacaine hydrochloride. (Marcaine, 25% vial, Astra Zeneca) diluted in 20 ml of 0.9% saline.

Drug: local ifiltration Bupivacaine, Meloxican and placebo
no other intervention done

Active Comparator: meloxicam group

included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with meloxicam 15mg (Anticox 2 ampoule 15mg/3ml, ADWIA Pharmaceuticals). diluted in 20 ml of 0.9% saline.

Drug: local ifiltration Bupivacaine, Meloxican and placebo
no other intervention done

Active Comparator: placebo group

included 35 patients in which skin and subcutaneous tissue was infiltrated with 20 ml 0.9% saline.

Drug: local ifiltration Bupivacaine, Meloxican and placebo
no other intervention done

Outcome Measures

Primary Outcome Measures

  1. Postoperative pain scores [immediately after the intervention]

    Assessment of pain scores after Cesarean section

  2. Postoperative analgesic requirements [immediately after the intervention]

    Assessment of Postoperative analgesic requirements

  3. time of first dose of analgesia [immediately after the intervention]

    Determination of time of first dose of analgesia

Secondary Outcome Measures

  1. Postoperative fever [immediately after the intervention]

    Assessment of Postoperative fever

  2. onset of mobilization [immediately after the intervention]

    Assessment of onset of mobilization

  3. side effects of medications [immediately after the intervention]

    Assessment of side effects of medications

  4. Pain assessment by visual analogue scale [immediately after the intervention]

    Post-operative pain assessment was done using a 10-point visual analogue scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Age between 21-40 years

  • Elective C.S at term

  • Patient having no medical disorders

  • Patient with no obstetrical complications

Exclusion Criteria:
  • extreme of reproductive age

  • allergy to local anesthetic infiltration agent

  • any medical disorders or obstetrical complications as ante partum hemorrhag, pre-eclampsia

  • refusal to participate in the trial.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Menoufia University hospital Shibīn Al Kawm Menoufia Egypt 11111

Sponsors and Collaborators

  • Menoufia University

Investigators

  • Principal Investigator: Mohamed E Anter, MD, Menoufia University hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Elsibai Anter, Lecturer of obstetrics and gynecology, Menoufia Obstetrics and Gynecology Group
ClinicalTrials.gov Identifier:
NCT04538391
Other Study ID Numbers:
  • 12/2019OBSGN38
First Posted:
Sep 4, 2020
Last Update Posted:
Sep 4, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 4, 2020